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Positron Emission Tomography(PET) in Lymphoma Assessment

NCT ID: NCT00887718

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-06-30

Brief Summary

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This study examines the role of a diagnostic test called Positron Emission Tomography (PET) scanning in patients with malignant lymphoma. The primary goal of this study is to find out how well PET scanning can detect malignant (cancerous) lymphoma, and how often this extra information will result in a change of stage of disease, or will result in a change in treatment management plans of patients with lymphoma.

Detailed Description

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It is currently unknown whether modifying treatment based on FDG-PET results is appropriate. However, clinicians are increasingly using the FDG-PET result, where obtained, in deciding management. Consequently, it would be premature to mandate PET-based treatment modifications in this protocol. Patients will be treated with existing protocols at the discretion of their treating oncologists, based on available information. Oncologists will be surveyed as to whether FDG-PET scan results could have (or affect patient management, and the intervention will be recorded).

Conditions

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Hodgkin's Lymphoma Non Hodgkin's Lymphoma

Keywords

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PET scan and Hodgkin's Lymphoma PET scan and Non Hodgkin's Lymphoma PET scan

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET scan for lymphoma assessment

Group Type EXPERIMENTAL

PET Scan

Intervention Type BIOLOGICAL

18F-Fluorodeoxyglucose (FDG) injection

Interventions

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PET Scan

18F-Fluorodeoxyglucose (FDG) injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients \> 18 years of age.
* Confirmed diagnosis of HL or NHL (any histology).
* Any Ann Arbor stage.
* Pre-treatment staging including CT of head and neck, chest, abdomen and pelvis, where there is a minimum one equivocal finding on the scan, affecting the assignment of stage or IPI factor (i.e. stage III/IV vs. stage I/II, or a question of extranodal involvement by disease).

Group B: Response Assessment


* Patients \> 18 years of age.
* Confirmed diagnosis of HL or NHL (any histology).
* Any Ann Arbor stage.
* Pre-treatment staging including CT neck, chest, abdomen and pelvis. If alternate assessment of the neck done by clinical palpitation, ultrasound, or MRI is negative, CT neck is not mandatory.
* Post-treatment staging including CT of head and neck, chest, abdomen and pelvis, at 1 - 6 weeks post-therapy.
* Treated with anthracycline-based chemotherapy, with or without radiation therapy (based on the stage of the disease). For Stage III/IV patients, PET will be done following completion of primary chemotherapy. For stage I/II patients, PET will be done after combined modality therapy, or after chemotherapy alone if this was the primary intention of therapy.
* Patients with residual mass on CT following primary chemotherapy with either "unconfirmed" CR (\>75% decrease in size) or PR (³50% decrease in size), based on International workshop criteria.

Exclusion Criteria

* None Curative treatment Intent
* After initial therapy the response status is: complete response, stable disease, or progressive disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Tsang, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Princess Margaret Hospital

Locations

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University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN REB 07-0235-C

Identifier Type: -

Identifier Source: org_study_id